eP372 - NoLapse: A Novel Stoma Prolapse Prevention Device

Purpose/Background: Stomal prolapse is a common complication of ostomies, with at least 100,000 incidents per year in USA. Prolapse can result in pain, bowel obstruction, and ischemia, has a high rate of recurrence after reduction, and can require urgent surgical revision. Currently, there are no non-surgical methods for prevention of initial or recurrent prolapse. We developed a medical device, NoLapse, for prevention of stomal prolapse. Here, we demonstrate safety and efficacy of the NoLapse device in an animal model and infants and adults with ostomies.Methods/Interventions: A proof-of-concept device was fashioned from FDA-approved medical tubing and sutures. The device consisted of two gastroschisis silo rings, one sitting below the fascia and one at the exit of the ostomy, connected by a central rod made of chest tube tubing and polypropylene sutures (Fig 1A). The makeshift device was successfully inserted into the stomas of infants and adults for emergency treatment of recurrent stomal prolapse. Subsequently, a prototype device (NoLapse) was molded out of semi-flexible, biocompatible silicone and sterilized via autoclave (Fig 1B). In a sheep model, a colostomy was created and manually prolapsed then reduced, followed by device placement. Dislodgment force was measured with a force gauge. Animals were monitored for obstructive symptoms, bleeding, and dehydration. Stomas were excised after 1-2 weeks for histopathological evaluation to assess intestinal mucosal injuries.Results/Outcomes: Four infants and one adult had the proof-of-concept device inserted for recurrent stomal prolapse (duration 1-195 days, Fig 1C-D). There were no adverse events related to device insertion, and no clinical evidence of recurrent obstruction, mucosal irritation, or bleeding for the duration of device use. The device did not interfere with ostomy appliance placement. The prototype silicone NoLapse device was inserted in two sheep for 1-2 weeks. The minimal pulling force required to dislodge the device was 12 newtons, however the device was easily removable when the rings were folded. No obstruction of stool passage or expulsion of the device was noted over the study period. Gross and histopathologic examination of the stoma and distal bowel post-necropsy noted no mucosal damage.Conclusion/

Discussion: The NoLapse is the first non-operative device for prevention of initial and recurrent stomal prolapse. We have demonstrated preliminary safety and efficacy of the device in both a large animal model and humans. Next steps include finalizing design specifications including sizes and a sizing kit, and initiation of a pre-approval clinical trial in adults.Figure 1(A) Proof-of-concept device design created from gastroschisis silo rings, silicone chest tubes, and suture. (B) NoLapse silicone prototype device made of a single piece of molded medical-grade silicone. Proof-of-concept device inserted in the ileostomy of an infant (C) and colostomy of an adult (D).